The Anspach Effort, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0715-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures

Product Classification:

Class II

Date Initiated: March 29, 2012

Date Posted: January 22, 2014

Recall Number: Z-0715-2014

Event ID: 67177

Reason for Recall:

Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.

Status: Terminated

Product Quantity: 492 (321 US)

Code Information:

ALL LOTS for product code 18-0001

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated